Steroid-Free Over-the-Counter Eczema Skin Care Formulations Reduce Risk of Flare, Prolong Time to Flare, and Reduce Eczema Symptoms in Pediatric Subjects With Atopic Dermatitis

not address barrier dysfunction and their long-term use is not recommended, particularly in children, due to the risk of cutaneous side effects, rebound flare-ups, suppression of growth rate, and reduced bone density.^4,6,8 Moreover, studies have shown that parents are reluctant to use steroids, with more than 50% delaying steroid treatment until flares have progressed to more severe presentations.^11,12 Hence, there is a need for steroid-free nonprescription therapies for the treatment of pediatric AD.

Two nonprescription products have been specifically developed for the care and treatment of eczematous skin—one developed as a daily maintenance moisturizer (Eucerin® Eczema Relief Body Crème, Beiersdorf, Wilton, CT) and the other for the acute treatment of AD lesions (Eucerin® Eczema Relief Flare Treatment). These over-the-counter (OTC) formulations are specifically designed to help restore optimal acidic skin pH, restore and maintain barrier function, and provide relief for pruritus and irritation due to eczema. Both formulations contain 1% colloidal oatmeal, a skin protectant used as a bath additive for centuries to alleviate itch¹³; licochalcone A, a retrochalcone from the root of Glycyrrhiza inflata that visibly helps relieve irritated skin¹⁴; and ceramide 3, an epidermal barrier lipid. The Flare Treatment product is formulated with a higher concentration of ceramides than the Body Cream to help promote barrier repair of lesional skin, and also contains menthoxypropanediol—a novel cooling agent that helps soothe itch.¹⁵ Both formulations have previously demonstrated efficacy and tolerability in trials involving adults¹⁶ and infants and children.¹⁷ In these studies, the Body Cream moisturizer effectively moisturized skin and improved and maintained barrier function, while the acute Flare Treatment reduced the severity of acute AD symptoms, significantly improved scores of itch intensity and duration, and reduced the impact of itch on life activities as measured by Elman’s 5-D itch questionnaire.^16,17

To further evaluate the role of these OTC formulations in the management of atopic disease, a randomized, controlled, 6-month prospective study was conducted to assess the efficacy of daily use of the Body Cream moisturizer in maintaining and prolonging the flare-free state of asymptomatic infants and children with AD relative to a control group, and to evaluate the efficacy of the acute Flare Treatment product to manage AD symptoms in subjects who experienced flare.

Infants and children from ages 3 months through 12 years were eligible for enrollment. Subjects were required to have a history of AD, as confirmed by a board-certified dermatologist, and meet the Hanifin and Rajka AD criteria.³ Subjects were excluded if they had active lesions/eczema flares at the time of enrollment. Parents/legal guardians of prospective subjects read and signed an Institutional Review Board-approved informed consent form prior to study enrollment.

Three products developed specifically by Beiersdorf Inc. (Wilton, CT) for the skin care and treatment of AD were used in this study: (1) a mild daily cleansing body wash formulated with a mild surfactant system (decyl glucoside, sodium myreth sulfate) and panthenol (cleanser) to provide gentle cleansing for atopic skin without drying; (2) a daily moisturizing body cream (Eucerin® Eczema Relief Body Crème, referred to hereafter as “Body Cream”); and (3) an acute therapy for active AD lesions (Eucerin® Eczema Relief Instant Therapy, referred to hereafter as “Flare Treatment”).

This single-center, randomized trial consisted of a washout phase (2 weeks), a maintenance phase (6 months), and a treatment phase (4 weeks) (Figure 1). Scheduled clinic evaluations took place at the baseline of the washout phase (visit 1), the baseline of the maintenance phase/conclusion of the washout phase (visit 2), and 4 weeks into the maintenance phase (visit 3). If a flare occurred, subjects entered the treatment phase and were assessed at onset, week 2, and week 4.

Parents/guardians were instructed not to use any topical moisturizing products on their children 2 days prior to visit 1, or any eczema treatment products for at least 5 days prior to the visit. At enrollment, subjects were randomly assigned to the moisturizer group (n=22) or the control group (n=23), and parents/guardians completed an eczema history questionnaire. All participants completed a 2-week washout phase in which a standardized